- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01507675
Burden, Belonging, and Response to Pain in Veterans
March 21, 2014 updated by: VA Eastern Colorado Health Care System
The primary purpose of the current study is to rigorously test the psychometric properties of the INQ-12 and ACSS (Van Orden et al., 2008) in Veterans, something which has not been done to date.
Factor structure, internal consistency, convergent and discriminant validity will all be assessed.
Secondary goals are to determine if burdensomeness, failed belongingness, and acquired capability are distinct versus overlapping constructs and whether or not values mediate the relationship between reasons for living and suicide risk.
Lastly, the inclusion of the Beck Scale for Suicidal Ideation (BSS) allows us to analyze participants' responses to explore whether or not participants can be grouped into those who want to die by suicide because they want to escape their problems and those who want to die to influence other people.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
Suicide is a significant problem among Veterans of the U.S. Military.
Katz (2007) reported that there were 144 suicides among Veterans who served in Operation Enduring Freedom (OEF) and/or Operation Iraqi Freedom (OIF) from 2002-2005.
There is no nationwide surveillance system that tracks Veteran suicides.
However, the National Violent Death Reporting System (NVDRS) created in 2003 by the Centers for Disease Control and Prevention (CDC) with the purpose of gathering thorough information about suicides and other violent deaths allows researchers to reasonably extrapolate national suicide rates for Veterans.
A CDC report (2006) based on NVDRS data estimated that approximately 6,500 veterans from all wars die by suicide each year, accounting for approximately 20% of suicides per year nationwide.
While much is known about risk factors for suicide (e.g., Beck, Steer, Kovacs, & Garrison, 1985; Jobes & Mann, 1999) such information has little clinical utility for predicting whether or not an individual is likely to die by suicide in the near-term.
One of the few attempts to address this issue is the interpersonal-psychological theory of suicide (Joiner, 2005).
The interpersonal psychological theory proposes that people die by suicide for three reasons: (1) they perceive themselves as a burden to others; (2) they experience a profound feeling of disconnectedness from others, what Joiner (2005) calls ''thwarted belongingness'' (p.
118); and (3) they have become habituated to the fear and physical pain inherent in a suicidal act by repeatedly enduring painful and provocative situations, whether through such experiences as repeated suicide attempts, other physically painful experiences, or frequent exposure to danger.
Importantly, all three factors must be present for a suicide to occur, according to the interpersonal-psychological theory; together, these three characteristics are ''proximal, causal, interactive risk factors'' (Van Orden, Witte, Gordon et al., 2008a, p. 72).
Components of the theory have been tested in adults (Joiner, Pettit, Walker, Voelz, Cruz, & Rudd, 2002; Joiner & Rudd, 2000), college students, and adolescents (Joiner, Rudd, Rouleau, & Wagner, 2000).
However, research has only begun to explore whether the theory applies to Veterans (Cornette, Deboard, Clark, Holloway, Brenner, Gutierrez, et al., 2007; Cornette, deRoon-Cassini, Joiner, & Proescher, 2006).
Brenner et al. (2008) conducted a qualitative study of OEF/OIF Veterans which found relevance of the theory to their experiences.
In particular, themes emerged around combat as a context for exposure to painful stimuli, perceptions of burdensomeness, and failed belongingness.
This theory shows promise for designing prevention and clinical intervention strategies for Veterans, but more data are needed on which to base such work.
To facilitate testing the interpersonal-psychological theory of suicide, Joiner and colleagues have developed several instruments (Bender, Gordon, & Joiner, 2007; Bryan, Morrow, Anestis, & Joiner, 2010; Van Orden,Witte, Gordon et al., 2008a).
The Interpersonal Needs Questionnaire (INQ) taps into the constructs of thwarted belongingness and perceived burdensomeness.
The Acquired Capability for Suicide Scale (ACSS; Van Orden et al., 2008) measures fearlessness about suicide.
The current study will focus on the 12-item version of the INQ (INQ-12; Van Orden, Witte, Gordon, Bender, & Joiner, 2008a) recently validated by Freedenthal, Lamis, Osman, Kahlo, and Gutierrez (2011).
This measure contains seven items that assess perceived burdensomeness and five items that assess belongingness.
An example of a burdensomeness item in the INQ-12 is, ''These days, I think I have failed the people in my life''.
An example of a belongingness item is, ''These days, other people care about me''.
The ACSS is a 20-item measure rated on a scale of 1 (not at all like me) to 5 (very much like me).
Sample items include, "I am not at all afraid to die" and "I can tolerate a lot more pain than most people".
Van Orden et al. report acceptable convergent and discriminant validity.
The authors also reported a strong negative correlation with the fear of suicide subscale on the Reasons for Living Inventory (RFL; Linehan, Nielsen, & Chiles, 1983) and a positive correlation with the courage to kill oneself item on the Beck Scale for Suicide Ideation (BSS; Beck & Steer, 1991).
Bender, Gordon, Bresin, and Joiner (2011) reported acceptable internal consistency as well.
However, formal psychometric studies of the ACSS have yet to be conducted.
Joiner (2005) describes burdensomeness, failed belongingness and acquired capability as separate constructs, with the INQ-12 and ACSS designed to assess each independently.
However, for purposes of explaining whether a given individual is likely to die by suicide, Joiner et al. (2009) explain that the first two constructs together create the desire for death and that the third is necessary for a person to engage in potentially lethal self-harm behavior.
Therefore, a complex interaction between the three is proposed.
Support for this interaction was found by Joiner et al. in two independent samples, one community sample of young adults and a second drawing on archival data from active duty military personnel being treated for a recent significant suicide-related event (e.g., serious ideation or attempt).
A major limitation of this study was that measures of the constructs differed, making it somewhat difficult to determine what was being assessed in the two samples.
Additionally, in their psychometric examination of the INQ-12 Freedenthal and colleagues (2011) found evidence of an overarching factor uniting the two subscales of burdensomeness and failed belongingness.
Assessing for suicide risk is a key element of the clinical management of high-risk individuals (Gutierrez et al., 2009), but is only the first step.
To adequately select appropriate interventions clinicians must know what is driving an individual's suicidality (Jobes, 2006) and also what factors are keeping the person from acting on their thoughts and urges.
This information better helps the clinician and client to develop strategies aimed at creating (or rediscovering) what makes life worth living; focusing on plans, goals, and hope for the future (Jobes, Comtois, Brenner, & Gutierrez, 2011).
Historically, the RFL (Linehan et al., 1983) has been one of the primary measures of protective factors against suicide, and indeed has shown great utility.
A potentially related area of study is the role of one's values.
The consciously chosen way in which an individual lives her life, the driving force behind her actions, and the desired outcomes of her behaviors define what an individual values (Luoma, Hayes, & Walser, 2007).
Helping clients live lives consistent with their values provides purpose and meaning, gives direction to their choices, and allows them to set reasonable, flexible goals likely to motivate meaningful action (Luoma et al.).
Accomplishing these things should greatly facilitate reducing an individual's risk of suicide, since it answers the fundamental existential question "why is life worth living?"
Ciarrochi and Bailey (2008) created the Survey of Life Principles to assess values, and provide preliminary support for its use in their manual.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Denver, Colorado, United States, 80220
- VA VISN 19 MIRECC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants will be recruited from all individuals eligible to receive care at the Denver VA Medical Center (DVAMC), regardless of clinic.
Description
Inclusion Criteria:
- Military veteran
- 18 or older
- Ability to respond to questions regarding the informed consent
Exclusion Criteria:
- Active-duty military
- Non-English speaking
- Inability to respond to questions regarding the informed consent procedure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Military Veterans
Participants will be recruited from the Denver VA Medical Center (DVAMC), regardless of clinic.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Internal consistency reliability.
Time Frame: two years
|
The internal consistency reliability statistics will be calculated for all study variables to confirm the measures are reliable.
|
two years
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Convergent validity.
Time Frame: two years
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Convergent validity of the Interpersonal Needs Questionnaire (INQ) will be determined by examining the correlation between it and the other study measures.
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two years
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Convergent validity.
Time Frame: two years
|
Convergent validity of the acquired capability of suicide scale (ACSS) will be determined by correlating it with all other measures.
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two years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discriminant validity.
Time Frame: two years
|
Discriminant validity of the interpersonal needs questionnaire (INQ) will be determined by examining correlations with measures of unrelated constructs.
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two years
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Suicide risk.
Time Frame: two years
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Examine the effects of scores on the SLP on the relationship between reasons that people have for living and the potential for engaging in at-risk behavior.
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two years
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Discriminant validity
Time Frame: two years
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Examine the discriminant validity of the acquired capability for suicide scale (ACSS) by examining correlations between it and measures of unrelated constructs.
|
two years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peter M. Gutierrez, PhD, Clinical Research Psychologist VA VISN 19 MIRECC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (ANTICIPATED)
April 1, 2014
Study Completion (ANTICIPATED)
April 1, 2014
Study Registration Dates
First Submitted
December 9, 2011
First Submitted That Met QC Criteria
January 6, 2012
First Posted (ESTIMATE)
January 11, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
March 26, 2014
Last Update Submitted That Met QC Criteria
March 21, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COMIRB 11-0948
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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